Directives. BREXIT. Notified Bodies.

Information on the current official EU Directives for EMC,LVD and RED (Radio Equipment Directive) Can be found here: https://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive_en

BREXIT:  EMCIA Member John Woodgate wrote this interesting article as far as we can tell this is still UpToDate. EMC Standards & Brexit   http://emcia.org/documents/brexit2.pdf

Keith Armstrong comments… After Brexit it is likely to be quite a while before anyone in the Government Civil Service has any time to consider changing any more than “shadowing” the EU Directives into UK law guess 5 years at least.  

The only urgent issue is what replaces EU Notified Bodies in the UK, and that has all been sorted (I understand) and the new UKCA mark drafted, to show that a UK Conformity Assessment Body has approved the product for the UK (to replace EU Notified Body approvals, where they were necessary - in most cases they aren't, except for certain Radio Equipment).

https://www.gov.uk/guidance/status-of-conformity-assessment-bodies-after-brexit

John Woodgate comments… A web search for "UK notified bodies after Brexit" produces some useful hits, but beware that some information is out-of-date.

Many UK-based NBs are setting up a 'presence' on the Continent, so they can continue to operate as usual, although they will need to be accredited by another body than UKAS. I expect the transition and post-transition negotiations will include a mutual recognition agreement of UKAS and the Continental accreditation bodies.

More info than you are ever likely to want:

https://european-accreditation.org/ea-members/directory-of-ea-members-and-mla-signatories/

EMC LVD RED:   Keith Armstrong has kindly provided an explanatory presentations as below.

Easy EMC & LVD Compliance with the RED       Link to File?                   

EU Directive into force in 2016/17 – Update July 2018          Link to File.?

Excellent Presentation from ETSI.

New Radio Equipment Directive.

ETSI Presentation by Dr. Mike North on the ramifications of New Radio Equipment Directive. As well as this PDF you can see an hour-long webinar on the ETSI web site. Click here. Link to File below

http://www.emcia.org/documents/ETSI%20RED.pdf

Medical Devices Directives:

90/385/EEC regarding active implantable medical devices (AMIDD)

93/42/EEC regarding medical devices (MDD)

98/79/EC regarding in vitro diagnostic medical devices (IVDD.)    For information on these three Directives Click here. Link to File below.

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Keith Armstrong has kindly provided a presentation on New Directive for Medical Devices November 2016. Click Here Link to File.

Keith can be contacted via his web site.  Click.  Link to file.  To EMC Standards

NOTE: For Medical Compliance please see documents in the Risk Management Section. Click here. Link to file.  http://www.emcia.org/functional-safety-risk-management.aspx